1. Subgroup‐adaptive randomization for subgroup confirmation in clinical trials
- Author
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Xuesi Ma, Zhaoliang Wang, and Zhongqiang Liu
- Subjects
Statistics and Probability ,Randomization ,Computer science ,Population ,Adaptive randomization ,Machine learning ,computer.software_genre ,01 natural sciences ,010104 statistics & probability ,03 medical and health sciences ,0302 clinical medicine ,Humans ,030212 general & internal medicine ,0101 mathematics ,education ,Randomized Controlled Trials as Topic ,education.field_of_study ,Randomization Procedure ,business.industry ,General Medicine ,Clinical trial ,Research Design ,Adaptive design ,Artificial intelligence ,Statistics, Probability and Uncertainty ,business ,computer - Abstract
A well-known issue when testing for treatment-by-subgroup interaction is its low power, as clinical trials are generally powered for establishing efficacy claims for the overall population, and they are usually not adequately powered for detecting interaction (Alosh, Huque, & Koch [2015] Journal of Biopharmaceutical Statistics, 25, 1161-1178). Hence, it is necessary to develop an adaptive design to improve the efficiency of detecting heterogeneous treatment effects within subgroups. Considering Neyman allocation can maximize the power of usual Z-test (see p. 194 of the book edited by Rosenberger and Lachin), we propose a subgroup-adaptive randomization procedure aiming to achieve Neyman allocation in both predefined subgroups and overall study population in this paper. To verify whether the proposed randomization procedure works as intended, relevant theoretical results are derived and displayed . Numerical studies show that the proposed randomization procedure has obvious advantages in power of tests compared with complete randomization and Pocock and Simon's minimization method.
- Published
- 2020